While Amneal cannot wait to jump into unexplored biologics space, it wants to channel its GLP-1 power into the Metsera partnership and service big pharma, and less so on its own generics.
Hungary’s Gedeon Richter and its Japanese partner Mochida have together unveiled plans to file their proposed Actemra/RoActemra biosimilar with major regulators, after biosimilar competition to the IL-6 receptor inhibitor materialized in the US last year.
As Bob Bradway addressed the J.P. Morgan Healthcare Conference in San Francisco, the Amgen chief executive discussed the firm’s biosimilars business – including an ocrelizumab rival to Ocrevus that has just been added to its pipeline. Meanwhile, the CEO also outlined his expectations for imminent biosimilar competition to Amgen’s Prolia and Xgeva denosumab brands.
Partners Fresenius and Formycon have racked up another pair of approvals for their Otulfi ustekinumab biosimilar rival to Stelara, this time in the UK and Canada.
At the 2025 J.P. Morgan Healthcare Conference, Johnson & Johnson outlined a new competition blueprint for anti-inflammatory biosimilars, going beyond the next blockbuster Tremfya.
In an exclusive interview with Generics Bulletin, Aspargo Labs CEO Michael Demurjian discusses the importance of reformulated liquid oral suspension drugs, while outlining plans to launch a smart device that connects patients and doctors.
Biocon Biologics has announced a change in regulatory status for a manufacturing plant in Malaysia that could pave the way for a pair of long-awaited FDA biosimilar approvals, after similar positive news for an Indian site late last year.
At the J.P. Morgan Healthcare Conference in San Francisco, Teva has provided a timeline for its much-talked-about long-acting injectable olanzapine candidate, after wrapping up a Phase III clinical trial with data that the firm believes will give it a major advantage over its competitors.
Teva has announced two major biosimilars deals in quick succession, partnering with Samsung Bioepis on its US Epysqli eculizumab rival to Soliris and Formycon on its European Ahzantive aflibercept challenger to Eylea.
ANI Pharmaceuticals will compete with a product bringing in annual sales of more than $150m after launching the first generic with 180-day exclusivity via the FDA’s competitive generic therapy pathway.
Celebrating its first birthday as a transformed and integrated company, Biocon casts a wider net for its ustekinumab biosimilar.
Alexion has been refused in its bid for injunctions to block the sale of Samsung Bioepis and Amgen’s European Soliris biosimilars, following a decision by the Court of Appeal of Europe’s Unified Patent Court.
Tanvex has seen its application for a trastuzumab biosimilar knocked back by the US Food and Drug Administration, receiving a complete response letter over the filing.
Aurobindo’s biosimilars business is continuing to gain momentum, with a UK approval for bevacizumab in hand and further European nods expected.
New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.
Xbrane is taking a third shot at filing its ranibizumab biosimilar rival to Lucentis with the US Food and Drug Administration. Will it succeed where it has previously failed to gain approval?
While Amgen had been expected to launch its Wezlana interchangeable biosimilar to Stelara from 1 January in the US, the firm has so far been quiet on details – including on the pricing strategy for its rival to the $10bn+ brand.
The FDA delivered its “Christmas gift” of approving Hikma’s generic Victoza, the first once-daily liraglutide injectable on the US market.
The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.